Effect of Nesting During Intramuscular Injection on Pain, Stress, and Breastfeeding Success in Cesarean-Born Term Newborns (NESTING)
2026년 8월 2일 업데이트: Emine Nur Çalımlı Celep, Istanbul University - Cerrahpasa
The Effect of Nesting Practice on Pain, Stress Level, and Breastfeeding Success During Intramuscular Injection in Term Newborns Delivered by Cesarean Section
This randomized controlled trial aims to evaluate the effect of nesting during the first intramuscular injection on pain, stress level, physiological parameters, settling time, and breastfeeding success in healthy term newborns delivered by cesarean section.
A total of 112 newborns will be randomly assigned in a 1:1 ratio to either a nesting intervention group or a routine care control group.
Newborns in the intervention group will receive nesting until the first intramuscular injection, whereas those in the control group will receive routine neonatal care.
Pain, stress level, physiological parameters, settling time, and breastfeeding success will be evaluated using validated assessment tools.
The findings are expected to provide evidence regarding the effectiveness of nesting as a simple, safe, and non-pharmacological intervention for reducing procedural pain and stress in newborns while supporting breastfeeding success.
연구 개요
상태
상태
모병
정황
정황
개입 / 치료
개입 / 치료
상세 설명
Painful procedures performed during the first hours after birth, particularly intramuscular vitamin K and hepatitis B injections, are associated with significant pain and stress responses in newborns. Although several non-pharmacological interventions have been recommended to minimize procedural pain, evidence regarding the effectiveness of nesting in healthy term newborns delivered by cesarean section remains limited.
This study is designed as a prospective, single-center, parallel-group, randomized controlled trial. The study will be conducted in the newborn observation room of the Delivery Unit at Kocaeli Darıca Farabi Training and Research Hospital. Healthy term newborns (37-42 weeks of gestation) delivered by cesarean section will be enrolled after written informed parental consent is obtained. A total of 112 newborns will be randomly allocated in a 1:1 ratio to either the nesting intervention group or the routine care control group using Random Allocation Software.
Newborns assigned to the intervention group will be placed in a sterile cotton nesting position until the first intramuscular injection. Routine intramuscular administration of vitamin K and hepatitis B vaccine will be performed according to standard neonatal care. The control group will receive routine neonatal care without nesting. No additional invasive procedures will be performed for research purposes.
Pain, stress level, heart rate, respiratory rate, oxygen saturation, and settling time will be assessed before, during, and one minute after the injection. Breastfeeding success will be evaluated at the first breastfeeding after mother-infant reunion, at one hour after breastfeeding, and before hospital discharge using validated assessment tools. Outcome assessment will be performed by an independent assessor who is blinded to group allocation.
The primary objective of this study is to determine whether nesting reduces procedural pain and stress while improving physiological stability and breastfeeding success in term newborns delivered by cesarean section. The results are expected to contribute to evidence-based neonatal care by supporting the implementation of developmental, non-pharmacological interventions during routine newborn procedures.
연구 유형
연구 유형
중재적
등록 (추정된)
등록
112
단계
단계
- 해당 없음
연락처 및 위치
이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.
연구 연락처
연구 연락처
- 이름: Emine Nur Çalımlı Celep, Msc
- 전화번호: +90 506 126 48 03
- 이메일: enurcalimli@gmail.com
연구 연락처 백업
- 이름: Yasemin Dinçel, MSc
- 전화번호: +90 545 939 49 26
- 이메일: yasemindincel96@gmail.com
연구 장소
-
-
Kocaeli
-
Darıca, Kocaeli, 터키 (Türkiye)
- 모병
- Kocaeli Darıca Farabi Training and Research Hospital
-
연락하다:
- Emine Nur Çalımlı Celep, Msc
- 전화번호: +90 506 126 48 03
- 이메일: enurcalimli@gmail.com
-
수석 연구원:
- Sevil İnal, Prof. Dr.
-
부수사관:
- Emine Nur Çalımlı Celep, Msc
-
부수사관:
- Yasemin Dinçel, Msc
-
-
참여기준
연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.
자격 기준
자격 기준
공부할 수 있는 나이
- 어린이
건강한 자원 봉사자를 받아들입니다
예
설명
Inclusion Criteria:
- Written informed consent was obtained from the parent(s) or legal guardian(s) of the newborn.
- Born by cesarean section.
- Term newborn (gestational age between 37+0 and 41+6 weeks).
- Birth weight between 2,500 g and 4,000 g.
- Clinically stable vital signs (including heart rate, respiratory rate, and oxygen saturation).
- No acute or chronic medical conditions.
- No congenital anomalies.
- No requirement for endotracheal intubation, resuscitation, or admission to the neonatal intensive care unit (NICU).
- Scheduled to receive the first intramuscular injection after birth.
Exclusion Criteria:
- Multiple birth (e.g., twins or higher-order multiples).
- Administration of vitamin K or hepatitis B vaccine before completion of the study procedures.
- Withdrawal of parental consent at any time during the study.
- Use of a pacifier, oral sucrose, or any pharmacological or non-pharmacological pain-relief intervention before completion of the outcome assessments.
- Discharge from the hospital or transfer to another healthcare facility before completion of the study procedures.
- Delayed mother-newborn reunion due to maternal general anesthesia or prolonged sedation following spinal or epidural anesthesia.
- Delayed transfer of the newborn to the mother because of prolonged surgery, intraoperative complications, or delayed postoperative stabilization.
공부 계획
이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 지지 요법
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 더블
팔의 수
2
무기와 개입
참가자 그룹 / 팔참가자 그룹 / 팔 |
개입 / 치료개입 / 치료 |
|---|---|
|
실험적: Nesting Group
Term newborns delivered by cesarean section will receive the nesting intervention before and during routine intramuscular injection.
Pain, stress level, and breastfeeding success will be assessed using validated outcome measures.
|
Nesting is a non-pharmacological positioning intervention in which the newborn is placed in a flexed, midline posture using rolled towels or positioning supports to provide containment before and during intramuscular injection.
The intervention aims to reduce procedural pain and stress and improve breastfeeding success.
|
|
간섭 없음: Standard Care Group
Term newborns delivered by cesarean section will receive routine care during intramuscular injection without the nesting intervention.
Pain, stress level, and breastfeeding success will be assessed using the same outcome measures.
|
연구는 무엇을 측정합니까?
주요 결과 측정
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Neonatal Pain
기간: Immediately before intramuscular injection, during intramuscular injection, and 1 minute after intramuscular injection.
|
Pain will be assessed using the Neonatal Pain, Agitation and Sedation Scale (N-PASS).
The pain/agitation component consists of five behavioral and physiological indicators, each scored from 0 to 2, yielding a total score ranging from 0 to 10. Higher scores indicate greater pain.
|
Immediately before intramuscular injection, during intramuscular injection, and 1 minute after intramuscular injection.
|
|
Neonatal Stress Level
기간: Immediately before intramuscular injection, during intramuscular injection, and 1 minute after intramuscular injection.
|
Neonatal stress will be assessed using the Neonatal Stress Scale.
The scale consists of eight behavioral and physiological indicators, each scored from 0 to 2, yielding a total score ranging from 0 to 16.
Higher scores indicate greater neonatal stress.
|
Immediately before intramuscular injection, during intramuscular injection, and 1 minute after intramuscular injection.
|
2차 결과 측정
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Heart Rate
기간: Immediately before intramuscular injection, during intramuscular injection, and 1 minute after intramuscular injection.
|
Heart rate will be measured in beats per minute (bpm) to evaluate the newborn's physiological response to intramuscular injection.
Higher heart rate values indicate a greater physiological response to procedural stress.
|
Immediately before intramuscular injection, during intramuscular injection, and 1 minute after intramuscular injection.
|
|
Respiratory Rate
기간: Immediately before intramuscular injection, during intramuscular injection, and 1 minute after intramuscular injection.
|
Respiratory rate will be measured in breaths per minute (breaths/min) to evaluate the newborn's physiological response to intramuscular injection.
Higher respiratory rate values indicate a greater physiological response to procedural stress.
|
Immediately before intramuscular injection, during intramuscular injection, and 1 minute after intramuscular injection.
|
|
Peripheral Oxygen Saturation
기간: Immediately before intramuscular injection, during intramuscular injection, and 1 minute after intramuscular injection.
|
Peripheral oxygen saturation (SpO₂) will be measured using pulse oximetry and reported as a percentage (%) to evaluate the newborn's physiological response to intramuscular injection.
Higher SpO₂ values indicate better oxygenation.
|
Immediately before intramuscular injection, during intramuscular injection, and 1 minute after intramuscular injection.
|
|
Breastfeeding Success
기간: At the first breastfeeding following mother-newborn reunion, 1 hour after the first breastfeeding, and 48 hours after birth (prior to hospital discharge).
|
Breastfeeding success will be assessed using the Bristol Breastfeeding Assessment Tool (BBAT).
The BBAT consists of four items (positioning, attachment, sucking, and swallowing), each scored from 0 to 2. Total scores range from 0 to 8, with higher scores indicating better breastfeeding effectiveness.
|
At the first breastfeeding following mother-newborn reunion, 1 hour after the first breastfeeding, and 48 hours after birth (prior to hospital discharge).
|
공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
수사관
수사관
- 수석 연구원: Sevil İnal, Prof. Dr., Istanbul University-Cerrahpasa, Department of Midwifery
연구 기록 날짜
이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.
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연구 기록 업데이트
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추가 정보
이 연구와 관련된 용어
기타 연구 ID 번호
기타 연구 ID 번호
- NESTING-2025-09
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
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